Indocyanine Green Fluorescence-guided Sentinel Node Biopsy in Breast Cancer Within a North African Population: a Retrospective Study

Background Radio Isotopes and Blue dye alone or in combination are the most commonly used tracer agents in sentinel Node Biopsy for early breast cancer. Recent studies have found fluorescence method using Indo Cyanine Green as a promising technology with fewer disadvantages. This study represents the first within a North African setting.

Methods Retrospective analysis of our database that includes patients with clinically node-negative breast cancer scheduled for breast surgery and SN biopsy between 2016 and January 2021. Patients who underwent detection using fluorescence-ICG were included in this study.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Sentinel Lymph Node
• Intervention / Treatment: Procedure: sentinel node detection

Detailed Description

We performed a retrospective review our data base that includes breast cancer planned for sentinel node biopsy at the F. Hached University teaching hospital(Sousse, Tunisia). Data between April 2016 and January 2021 were reviewed. Only non-pregnant or lacting adult female patients without palpable clinical node and considered suitable for such procedure at multidisciplinary meeting were included. We excluded from our analysis the first ten cases considered as a learning curve Same operator (SH) carried out all the procedures.

Under general anesthesia 5 ml at 2.5mg/ml of Infracyanine ® were injected circumferentially around the areola. Two ml of patent blue-V dye (Laboratoire Guerbet, Aulney-Sous-Bois, France) were injected in combination in the cohort of patients undergoing the procedure after primary chemotherapy. This was followed by a breast massage to facilitate absorption into the lymph vessels, then the surgical lights were turned off and image were obtained under near-infrared light using a first generation Near Infra Red device . Course of subcutaneous lymphatic drainage pathway fluorescence was followed up to where it disappeared to enter to deeper axilla and an incision was performed at that place. Lymphatic duct identification using the NIR camera allowed localization and removal of the sentinel lymph node(s). Further fluorescent imaging was performed to identify potential residual signal in the axilla and such signal-sites were removed. Following ICG assisted-dissection, blue-stained nodes were excised if any. All detected sentinel node were send for frozen section and processed for histological examination. After sentinel node biopsy, conservative surgery or mastectomy were performed according to indication and axillary dissection was performed according to international guidelines.

Statistical analysis Baseline patient's and tumor characteristics, Identification Rate of the sentinel node with Indocyanine green and with dye , when used, were recorded. Data were entered and analyzed in Excel. The continuous variables are presented as mean ± standard deviation and categorical variables are presented as count and percentages unless specified. Informed consents from each patient and IRB approval were obtained

• Study Type: Observational
• Enrollment (Actual): 47

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

47 patients who underwent SN biopsy using the above-mentioned technique were included. Mean age at time of surgery was 50.1 years (range 24-78 years).

Description

Inclusion Criteria:

• non-pregnant or lacting adult female patients with breast cancer without palpable clinical node and considered suitable for such procedure at multidisciplinary meeting were included

Exclusion Criteria:

• Non eligible patient for breast cancer sentinel node procedure

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
identification rate	percentage of cas in whom sentinel node was identified with fluoresence method	5 years

Collaborators and Investigators

• Sponsor: Faculty of Medicine, Sousse
• Investigators: Principal Investigator: Samir Hidar, Prof. M.D, F.Hached university teaching hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 10, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: breast cancer; sentinel node
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CEFMS 82/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No